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Serving leading biopharmaceutical companies globally:

Novartis
Covington
Daiichi Sankyo
McKinsey
US Army
Accenture
Express Scripts
Johnson and Johnson
Cantor Fitzgerald
Mallinckrodt

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021802

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NDA 021802 describes FOCALIN XR, which is a drug marketed by Novartis and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and six Paragraph IV challenges. Additional details are available on the FOCALIN XR profile page.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 021802
Tradename:FOCALIN XR
Applicant:Novartis
Ingredient:dexmethylphenidate hydrochloride
Patents:2
Therapeutic Class:Central Nervous System Agents
Pharmacology for NDA: 021802
Medical Subject Heading (MeSH) Categories for 021802
Suppliers and Packaging for NDA: 021802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0430 N 0078-0430-05
FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0431 N 0078-0431-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 26, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 26, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION

Expired US Patents for NDA 021802

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Covington
QuintilesIMS
Boehringer Ingelheim
UBS
McKinsey
McKesson
Chinese Patent Office

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